FDA Authorizes Marketing of Six Nicotine Pouches

On December 19, the U.S. Food and Drug Administration (FDA) authorized the marketing of six nicotine pouch products through the premarket tobacco product application (PMTA) pathway.

The authorizations are the first decisions from a pilot program launched in September to streamline the review process for nicotine pouch applications. The FDA said it implemented “several changes” to its review process and completed the review “in record time” under the new program.

The authorized products are made by Helix Innovations LLC and are sold under the on! PLUS brand. The products include:

• on! PLUS nicotine pouches Mint, 6 mg
• on! PLUS nicotine pouches Mint, 9 mg
• on! PLUS nicotine pouches Tobacco, 6 mg
• on! PLUS nicotine pouches Tobacco, 9 mg
• on! PLUS nicotine pouches Wintergreen, 6 mg
• on! PLUS nicotine pouches Wintergreen, 9 mg

“Today’s marketing authorizations confirm that rigorous and efficient standards of scientific review are not mutually exclusive,” said Bret Koplow, Ph.D., J.D., acting director of the FDA’s Center for Tobacco Products.

The actions are specific to the six products only and do not apply to any other Helix Innovations LLC products.

In January of this year, FDA authorized the marketing of 20 Zyn nicotine pouch products through the PMTA pathway, marking the first time the agency authorized products commonly referred to as nicotine pouches.

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